Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:14 PM
Ignite Modification Date: 2025-12-25 @ 2:12 PM
NCT ID: NCT04218266
Description: None
Frequency Threshold: 0
Time Frame: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Study: NCT04218266
Study Brief: Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Asundexian 50 mg Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks 4 None 20 254 116 254 View
Asundexian 20 mg Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks 2 None 22 249 110 249 View
Apixaban Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks 5 None 20 250 113 250 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure chronic NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Sinus arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial thrombosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Tachyarrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Congestive cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Sinus node dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Sudden cardiac death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Campylobacter gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Ejection fraction decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Bladder neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Lung adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Colon neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Peripheral sensorimotor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Completed suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Bronchial haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Cardiac ablation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Percutaneous coronary intervention NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia supraventricular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Autoimmune thyroiditis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Myopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Hernia pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pulpitis dental NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Tinea cruris NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lip injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Post-traumatic pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Skin wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Diabetes mellitus inadequate control NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Fluid overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Folate deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperuricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hypertonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Neuritis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Parkinsonism NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Orthostatic intolerance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Nightmare NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Sputum discoloured NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Hydrothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pharyngeal paraesthesia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pharyngeal swelling NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure chronic NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiomegaly NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Coronary artery stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Accessory spleen NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24.0 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Vertigo labyrinthine NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Swelling of eyelid NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Change of bowel habit NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Oral discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Saliva altered NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Large intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal symptom NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling abnormal NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vessel puncture site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Medical device site inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Cholestasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hepatic fibrosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hepatomegaly NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Amyloidosis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gingival abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Infective exacerbation of chronic obstructive airways disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Oral fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Facial bones fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Haematuria traumatic NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Inflammation of wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Blood potassium increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood thyroid stimulating hormone decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood thyroid stimulating hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Heart rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Reticulocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Urinary occult blood positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Angiocardiogram NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Limb discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Ageusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Essential tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Head discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Emphysema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Intertrigo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Papule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin fissures NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin haemorrhage NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Cardiac pacemaker insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Cardioversion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Tooth extraction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Cataract operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Circulatory collapse NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Peripheral coldness NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Phlebitis superficial NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Subclavian artery thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypertensive urgency NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Polycythaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Spontaneous haematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Aortic valve stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View